NCT01145742

Brief Summary

Many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control. There is an urgent need to enhance treatment for those who do not reach goals within the usual clinical care system. We propose to develop a multi-component intervention grounded in the Chronic Care Model, and sustainable in resource-challenged settings. Through collaboration with home health nursing and with the use of home telemetry for feedback and intensification of therapy, we will augment usual clinical services to improve health outcomes for diabetes patients who have not been able to reach therapeutic goals. There are three specific aims. First, we will establish a feasible, practical and sustainable collaborative model between the primary care sites of our practice-based research network (NYC RING), clinical researchers at the Diabetes Research and Training Center, and The Montefiore Home Health Organization, integrating the unique expertise of each of the partners and defining the roles and responsibilities of each. Second, we will develop and refine the components of the intervention, to include training primary care providers and home health nurses to integrate the technical, psychosocial and communication processes for implementation of the intervention. Third, we will assess the feasibility of the collaborative intervention by implementing the intervention for 25 primary care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25 patients receiving usual care. Our proposal includes plans to develop feasible procedures for data collection, with qualitative and quantitative methods of assessing process and outcome measures. We will use these preliminary data to revise the intervention and prepare an R18 application to further develop and test the intervention in multiple inner-city primary care sites serving low-income diabetes patients. This proposal is for secondary prevention of diabetes complications, targeting a population known for health disparities and a high burden from this chronic disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

June 15, 2010

Last Update Submit

December 10, 2018

Conditions

Type 2 DiabetesHypertensionHyperlipidemia

Keywords

Type 2 diabetesHypertensionHealth services researchHealth disparitiesBehavior change

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Change in blood pressure, measured at partipants' homes, between baseline and 6 months

    baseline and 6 months

Secondary Outcomes (2)

  • Hemoglobin A1c

    baseline and 6 months

  • LDL Cholesterol

    baseline and 6 months

Study Arms (2)

self-management support and BP telemonitoring

EXPERIMENTAL

collaborative intervention involving home BP monitoring, home behavior change counseling to enhance self management, and intensification of treatment by primary care doctors

Behavioral: home health/primary care collaboration

usual care

NO INTERVENTION

usual primary care management of BP. lipids, and glucose

Interventions

home health/primary care collaborationBEHAVIORAL

self-management support and telemonitoring of BP and blood glucose

self-management support and BP telemonitoring

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes,
  • BP above 140/90 on two health center visits,
  • home touch tone phone

You may not qualify if:

  • dementia,
  • homelessness,
  • language other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10705, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionHyperlipidemias

Interventions

Home Care Services

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesNursing Services

Study Officials

  • Melissa Diane McKee, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., Dept Family and Social Medicine

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 17, 2010

Study Start

November 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

US(1)